Specialist Engineering & Compliance Services

Synertec has broad experience in compliance with GMP and a range of national and international regulation and standards. The detailed knowledge and understanding of US FDA, ICH, PIC/S, SOX and ISO standards gained from the hands on experience as production/QA personnel or as auditors working within production and laboratory environments.

This knowledge and experience enables Synertec to develop and implement practical solutions that are embraced by Quality, Production and Engineering personnel.

Training engineers in Australia

Synertec personnel have expertise and consulting experience in:

  • Vendor Assurance
  • Audit readiness inspections
  • Change Control
  • Maintenance/Asset management
  • Calibration
  • Training and GMP Training
  • Process Analytical Technologies
  • Environmental Monitoring
  • Building Management systems
  • SOP Development
  • Quality Management and Documentation Systems
  • 21CFR part 11
  • Regulatory requirements
  • Computer & Software Validation